# K013066: HX-5/6-1 Endoscopic Clipping Device

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Dec 11, 2001 after 90 days
- Product code: MND (Ligator, Esophageal)
- Device class: 2
- Regulation: 21 CFR 876.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K963160 (1997). 2 ancestors in all.
53 later devices descend from it; 2 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963160: HX-5/6-1 Endoscopic Clipping Device, Olympus America, Inc. (1997) Summary page 4.
- K990687: HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips, Olympus Optical, Co. (1999) Summary page 4.

## Most influential descendants
- K040148: Resolution Hemostasis Clipping Device (2004), 48 descendants of its own
- K122660: Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 (2012), 39 descendants of its own
- K142973: Resolution Clip (2014), 23 descendants of its own
- K151802: Resolution Clip (2015), 19 descendants of its own
- K152001: Sterile Repositionable Hemostasis Clipping Device (2015), 15 descendants of its own

## Recalls of this device
- Feb 23, 2023 · Class II · Z-1418-2023: There have been complaints that the clip did not come out of the tube sheath during the procedure.

## Indications for use
Olympus HX-5/6-1 Rotatable Clip Fixing Devices are designed to be used for the following indications:

Source page: https://510kreport.com/device/K013066
Methodology: https://510kreport.com/methodology